One of the major issues with SPL R3 submissions is that SPL authors are continuing to change the setID for each revision of their SPL document. To replace a version of an SPL document which is on DailyMed with a newer version that has a different setID, FDA must coordinate with NLM to manually withdraw each outdated version of an SPL document which has to be replaced with a newer version with a different setID. This is time consuming and impacts the amount of time it takes for FDA to transmit updated versions of an SPL document to DailyMed. SPL R4 documents with this issue will fail validation and the SPL authors will be expected to make the correction to the setID and resubmit before FDA will release the document to DailyMed.
SPL Release 3 (R3)
This is the version loadable into ELIPS - the FDA's first SPL repository.
When the newest SPL release, Release 4 (R4) is fully implemented, ELIPS will be retired.
Content-of-labeling created in R3 can continue to go through the application submission process
New workflow for SPL documents in both R3 and R4 has been detailed in a diagram here.
Reminder - Retain setid across Versions of SPL
[02-Mar-2009]One of the major issues with SPL R3 submissions is that SPL authors are continuing to change the setID for each revision of their SPL document. To replace a version of an SPL document which is on DailyMed with a newer version that has a different setID, FDA must coordinate with NLM to manually withdraw each outdated version of an SPL document which has to be replaced with a newer version with a different setID. This is time consuming and impacts the amount of time it takes for FDA to transmit updated versions of an SPL document to DailyMed.
SPL R4 documents with this issue will fail validation and the SPL authors will be expected to make the correction to the setID and resubmit before FDA will release the document to DailyMed.
SPL Release 3 (R3)